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PT/INR test strip

by Helixgen (GUANGZHOU) Co., Ltd. China EUDAMED

Ref HZ-200124 EMDN W0103020801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06953792720134 Basic UDI-DIDate27 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PT/INR test strip
Model / Reference
HZ-200124
Primary DI / UDI-DI
06953792720134
Basic UDI-DI
B-06953792720134
EMDN Code
W0103020801 Prothrombin time rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000034593
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Helixgen (GUANGZHOU) Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 359f28a7-c44f-45c6-9c11-c7ce2e004aa7 61 fields · synced 22 Oct 2026